We are certified to ISO 9001:2015 and ISO 15378:2017 standards, and operate in full compliance with current GMP requirements.
QUALITY MANAGEMENT SYSTEM.
DEVELOPMENT AND MANUFACTURE OF PLASTIC PRIMARY PACKAGING FOR MEDICAL AND PHARMACEUTICAL PRODUCTS.
Our certification for the production of Class I Medical Devices according to Directive 93/42/EEC, Annex V, is currently on hold. But we have kept all procedures in place so we can readily undergo the re-certification audit and resume full compliance to manufacture Class I Medical Devices with CE-mark and with measuring function.